A comparison of sedatives used during gastroscopy, alfentanil vs midazolam
Phase 1
- Conditions
- Sedative effect during gastroscopyTherapeutic area: Not possible to specify
- Registration Number
- EUCTR2018-000026-54-SE
- Lead Sponsor
- Medicinkliniken, Sjukhuset Lidköping
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Patient between 18-80 years old
Refererred for policlinical routine gastroscopy
In need of sedative agent
Patient can communicate
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
Exclusion Criteria
Allergies to any of the used agents
Unable to communicate
Any planned therapuetical interventions
Patient has a suspected alcohol, narcotic och abuse of other drugs, or previous abuse
Pregnant patient
Severe lung disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate if midazolam and alfenatnil have same sedative effect and if rapifed;Secondary Objective: If rapifes has less post procedural side effect;Primary end point(s): If the patient can leave the practice earlier if given Alfentanil<br>If the sedative effect is non-inferior to midazolam;Timepoint(s) of evaluation of this end point: Evaluation when patient leaves the practice
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Number of examinations cancelled or aborted due to ineffective sedation. Patients experience of the examination. The doctors experience of the sedatives potency. comparison of side eccets. If the patient can see themselves undergo a new examination in the furutre.;Timepoint(s) of evaluation of this end point: During the examination and when the patient leaves the practice